Two stakeholders give FDA technical comments on a guidance based on an International Council for Harmonization guideline on drug interaction studies.
FDA publishes a guidance on 510(k) submissions for computer-assisted detection devices applied to radiology images and device data.
FDA issues a revised final guidance entitled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiol...
FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.
FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.
FDA updates its Covid-19 test policy to send more tests through the traditional review pathways and away from emergency use authorizations.
Federal Register notice: FDA modifies the organizational structure of the Office of Regulatory Affairs and field offices.
FDA publishes a guidance explaining the scope of its oversight of clinical decision support software in light of changes mandated by the 21st Century ...
